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Efficacy of the SeQuent®Please in the Treatment of De-novo Stenoses Versus Taxus™Liberté™ (PEPCAD-DEBonly)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01084408
First Posted: March 10, 2010
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bruno Scheller, University Hospital, Saarland
March 9, 2010
March 10, 2010
May 12, 2016
March 2010
March 2019   (Final data collection date for primary outcome measure)
Late lumen loss [ Time Frame: 6 months ]
Late lumen loss = MLD in-lesion initially - MLD in lesion after six months (after nitroglycerin in identical projections); assessment by an independent Core Lab.
Same as current
Complete list of historical versions of study NCT01084408 on ClinicalTrials.gov Archive Site
  • Thrombotic occlusion of the target lesion [ Time Frame: 30 days, 6, 12, 24, 60 months ]
  • Revascularization of the target lesion [ Time Frame: 30 days, 6, 12, 24, 60 months ]
  • Myocardial infarction [ Time Frame: 30 days, 6, 12, 24, 60 months ]
  • Death [ Time Frame: 30 days, 6, 12, 24, 60 months ]
  • Combined clinical endpoint (MACE) [ Time Frame: 30 days, 6, 12, 24, 60 months ]
    consisting of thrombotic occlusion of the treated segment, target lesion revascularization, myocardial infarction, or death
Same as current
Not Provided
Not Provided
 
Efficacy of the SeQuent®Please in the Treatment of De-novo Stenoses Versus Taxus™Liberté™
Randomized Trial on the Treatment of Coronary De-novo Lesions With a Drug Eluting Stent or a Drug Coated Balloon
The aim of the trial is to assess the efficacy of the Paclitaxel-coated SeQuent®Please angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a drug eluting stent.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary De-novo Stenoses
  • Device: SeQuent®Please (Paclitaxel coated balloon)
    PCI of de-novo lesions
  • Device: Taxus™Liberté™ (Paclitaxel eluting stent)
    PCI of de-novo lesions
  • Active Comparator: Sequent®Please
    Intervention: Device: SeQuent®Please (Paclitaxel coated balloon)
  • Active Comparator: Taxus™Liberté™
    Intervention: Device: Taxus™Liberté™ (Paclitaxel eluting stent)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
March 2020
March 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years
  • Clinical evidence of stable or unstable angina or a positive functional study
  • Single, stenotic de novo lesion in a native coronary artery, type A or selected B1 (see 4.3.1.1 Definition of lesion types)
  • Diameter stenosis > 70% (visual estimate)
  • Vessel diameter 2.5 - 3.5 mm
  • Female patients can enter this study if they are post-menopausal for at least two years or have undergone hysterectomy or sterilization
  • Signed patient informed consent form
  • Patient's and treating physician's agree that the patient will return for all required post procedure follow-up assessments as defined in the clinical protocol

Exclusion Criteria:

  • Left ventricular ejection fraction of < 30%
  • Visible thrombus proximal to the lesion
  • Expection that treatment with devices other than PTCA will be required for this lesion.
  • Stenosis is within a bypass graft
  • Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated
  • Other medical illness (i.e. cancer, liver disease or congestive heart failure) that may require cytostatic or radiation therapy, cause the subject to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than two years).
  • Acute myocardial infarction within the past 72 hours of the intended treatment (de-fined as: Q wave infarction having total creatinine kinase (CK) >3 times the upper normal limit, or CK remains elevated above hospital normal at time of treatment)
  • Chronic renal insufficiency with serum creatinine > 2.0 mg%
  • Significant gastrointestinal (GI) bleed within the past six months.
  • History of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • Extensive peripheral vascular disease that precludes safe 6 French sheath insertion and / or requires additional anti-platelet and / or anti-coagulation treatment.
  • Participating in another device or drug study within the last 6 months which may inter-fere with the interpretation of results of this study
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01084408
Pac 14
No
Not Provided
Not Provided
Bruno Scheller, University Hospital, Saarland
University Hospital, Saarland
Not Provided
Principal Investigator: Bruno Scheller, Prof. Dr. med Uniklinikum des Saarlandes
University Hospital, Saarland
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP